Consent Documentation Audit

This project audits whether consent documentation demonstrates an adequate decision-making process. It reviews whether the intervention is clearly documented, whether the consent discussion is recorded, whether capacity and voluntariness are addressed according to local policy, whether benefits, material risks, reasonable alternatives and the option of no treatment are documented, whether communication support and written information are recorded, whether the consent form is complete and matches the planned procedure, and whether refusal, withdrawal, best-interests decisions and pre-procedure reconfirmation are documented.

• Doctors, surgeons, anaesthetists, nurses, ACPs and PAs seeking consent within local scope
• Endoscopy, radiology, interventional and outpatient procedure teams
• Ward leaders, GP practice teams and independent clinic leads
• QI leads, governance and patient safety teams
• Supervisors and medical educators supporting ARCP and appraisal evidence

• Measure whether the consent discussion, not just the form, is documented
• Assess documentation of capacity, voluntariness and best-interests decisions
• Review risks, benefits, alternatives and the option of no treatment
• Test communication support, written information and form quality
• Generate governance-ready and ARCP-ready evidence and a re-audit cycle

• Anonymous case identifier
• Inclusion / eligibility decision
• Anonymised context (age band, sex/gender recorded, care setting, consent context)
• Clinical area / location and optional specialty / service
• Twenty-two consent documentation criteria (met / not met / not applicable)
• Free-text learning points and any project custom fields

• Live dashboard
• Audit report (Word)
• Executive summary (Word)
• Excel workbook
• PowerPoint presentation
• Conference poster
• ARCP evidence summary

This ready-built project is developed using the guidance, standards and authoritative sources listed below, so you can see what is being measured and why. Lazomis QI does not publish or own this guidance, and inclusion here does not imply endorsement or approval by any of these organisations.

• General Medical Council

  Decision making and consent(opens the original source in a new tab)

  Professional standard for the consent dialogue, material risks, reasonable alternatives and recording decisions.

• Care Quality Commission

  Regulation 11: Need for consent(opens the original source in a new tab)

  Regulatory requirement for lawful, documented consent and for acting under the Mental Capacity Act where capacity is lacking.

• Department of Health and Social Care

  Reference guide to consent for examination or treatment(opens the original source in a new tab)

  Reference framework for consent, capacity, children and young people, and documentation of decisions.

• NICE

  NG197: Shared decision making(opens the original source in a new tab)

  Guidance on shared decision making, risk communication, patient priorities and supporting information.

• NICE

  NG108: Decision-making and mental capacity(opens the original source in a new tab)

  Guidance on assessing capacity, supported decision making and best-interests decisions.

• NICE

  CG138: Patient experience in adult NHS services(opens the original source in a new tab)

  Standards for information, communication support and involving patients in decisions about their care.

• Legislation

  Mental Capacity Act 2005(opens the original source in a new tab)

  Statutory framework for capacity assessment and best-interests decisions where a patient cannot consent.

• Local policy

  Local consent, shared decision-making, MCA / best-interests, interpreter and chaperone policies

  Local consent policy, procedure-specific consent forms and leaflets, staff eligibility to seek consent, two-stage consent, interpreter and accessible communication arrangements, chaperone policy, procedural checklists and EPR documentation locations define what is required locally. Confirm local policy before setting targets. Paediatric and maternity consent criteria apply only where locally included.

• Designed to use anonymised or pseudonymised audit identifiers.
• This tool supports, but does not replace, clinical judgement.
• Local policy, formulary and specialist advice should be followed.
• Organisations remain responsible for local governance arrangements.
• This tool supports documentation review only. It does not provide legal advice, patient-specific consent advice or procedure-specific risk counselling.
• Consent forms, procedure-specific requirements, staff eligibility to seek consent, two-stage consent and EPR documentation locations are locally configured and are not presented here as national standards.
• Use anonymous case identifiers only — never patient-identifiable information.

Supporting guidance from the Lazomis QI Resource Library. Authoritative clinical standards referenced by this project remain separate.

• Clinical GovernanceLeveraging Incident Themes for Quality Improvement and Patient SafetyThis guide helps NHS teams identify and analyse recurring incident themes, transforming reported safety events into practical quality improvement opportunities to enhance patient safety and system reliability.
• Clinical GovernanceIntegrating Quality Improvement into Clinical Governance FrameworksThis article explores the vital relationship between Quality Improvement (QI) and Clinical Governance within the NHS, demonstrating how they are two sides of the same coin when aiming for continuous, systematic improvement in patient care.
• Patient SafetyIntegrating Patient Safety and Quality Improvement: A Practical Guide for UK CliniciansThis guide explains the foundational principles of patient safety and quality improvement (QI) within the UK healthcare context, offering practical strategies for clinicians to enhance safety and improve care delivery.
• Patient SafetyHow to Select a Patient Safety Quality Improvement ProjectThis guide helps NHS teams identify and select patient safety quality improvement (QI) projects that are impactful, achievable, and aligned with organisational and national priorities. Learn how to move from identifying concerns to choosing a focused and measurable project.